· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and

Revision of previously failed total hip arthroplasty.
The EcoFit® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.

Device Description

The EcoFit® Vit E Acetabular System is a line extension of EcoFit® Hip System, a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The EcoFit® Vit E Acetabular System adds additional liners, CoCr femoral heads, and Biolox® delta heads to the currently cleared system. Additionally, Vit E liners are added as compatible components in the system.

AI/ML Overview

This FDA 510(k) summary for the EcoFit® Vit E Acetabular System does not describe an AI medical device or a clinical study in the typical sense that would involve acceptance criteria and performance against a ground truth as commonly found in AI/ML reviews. Instead, it concerns a medical device (a hip replacement system) and its substantial equivalence to previously cleared predicate devices. Therefore, the questions about acceptance criteria, ground truth, sample sizes for test and training sets, expert adjudication, and MRMC studies are not applicable in this context.

The document primarily focuses on:

Indications for Use: The conditions for which the hip replacement system is intended.
Device Description: What the system is and how it extends a previously cleared system.
Performance Testing: A list of engineering and materials tests performed to ensure the device meets mechanical and material specifications, rather than clinical performance against a diagnostic or predictive outcome.
Substantial Equivalence: The primary basis for clearance, demonstrating that the new device is as safe and effective as existing legally marketed predicate devices.

Summary of Device Acceptance:

The device is accepted based on its substantial equivalence to predicate devices in terms of materials, indications, function, and/or performance. This is demonstrated through a series of non-clinical performance tests that evaluate the physical properties and mechanical behavior of the components.

Table of "Acceptance Criteria" (interpreted as engineering performance tests) and "Reported Device Performance":

Acceptance Criteria (Test Performed)	Reported Device Performance
Modular Disassembly	Performed as intended
Normal Wear	Performed as intended
Abrasive Wear	Performed as intended
Impingement	Performed as intended
Range of Motion	Performed as intended
UHMWPE Particle Analysis	Performed as intended
UHMWPE Characterization	Performed as intended
Ceramic Burst	Performed as intended
Ceramic Axial Fatigue	Performed as intended

Note: The document states "All necessary testing has been performed for the worst-case configuration... to assure substantial equivalence... and to demonstrate the subject devices perform as intended." It does not provide specific numerical outcomes or thresholds for these tests, only that they were completed and demonstrated performance as intended for substantial equivalence.

Regarding the other questions:

Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical test units of the device, not a dataset for an AI model.
Number of experts used to establish the ground truth... and qualifications: Not applicable, as there's no diagnostic or predictive "ground truth" being established by experts in this context.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
The type of ground truth used: Not applicable. Performance is assessed against mechanical and material standards, not a diagnostic ground truth.
The sample size for the training set: Not applicable, as there is no training set for an AI model.
How the ground truth for the training set was established: Not applicable.

Summary

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July 20, 2018

implantcast Gmbh % Dave Mcgurl Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001

Re: K180263

Trade/Device Name: EcoFit Vit E Acetabular System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, OQI Dated: June 21, 2018 Received: June 22, 2018

Dear Dave Mcgurl:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180263

Device Name EcoFit® Vit E Acetabular System

Indications for Use (Describe) The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
· Rheumatoid arthritis;

· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and

Revision of previously failed total hip arthroplasty.
The EcoFit® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

Device Trade Name:	EcoFit® Vit E Acetabular System
Manufacturer:	implantcast GmbHLueneburger Schanze 2621614 BuxtehudeGermany
Contact:	Ms. Juliane HöppnerPhone: +49 4161 744-135Fax: +49 4161 744-200j.hoeppner@implantcast.de
Prepared by:	Mr. Dave McGurlDirector, Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5797Fax: 202.552.5798dmcgurl@mcra.com
Date Prepared:	July 12, 2018
Classification:	21 CFR 888.3353
Class:	II
Product Codes:	LZO, OQIPrimary Predicate Device: implantcast GmbH EcoFit® Hip System (K163577)
Additional Predicates:	Zimmer, Inc. Continuum and Trilogy Cups (K091508)Aesculap, Inc. Acetabular Cups Plasmacup® SC (K042344)Aesculap, Inc. Plasmacup® NSC (K061699)Total Joint Orthopedics, Inc.Klassic HD Acetabular Insert With E-Link Poly (K141972)MicroPort Orthopedics, Inc. PROCOTYL® PRIME E-CLASS™ XLPE Liner (K171181)MicroPort Orthopedics, Inc. PROCOTYL® L-O AcetabularSystem (K142119)Zimmer GmbH Avenir Muller Stem (K123392)

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Indications for Use:

The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
Rheumatoid arthritis:
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the ● proximal femur with head involvement that are unmanageable by other techniques: and
. Revision of previously failed total hip arthroplasty.

The EcoFit® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.

Device Description:

Performance Testing:

All necessary testing has been performed for the worst-case configuration of the EcoFit® Vit E Acetabular System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the EcoFit® Acetabular System was characterized through the following tests:

Modular Disassembly ●
Normal Wear
Abrasive Wear
Impingement
Range of Motion ●
UHMWPE Particle Analysis ●
UHMWPE Characterization ●
Ceramic Burst ●
Ceramic Axial Fatigue ●

Substantial Equivalence:

The EcoFit Vit E Acetabular System is substantially equivalent in materials, indications, function and/or performance to the predicate devices (K163577, K091508, K042344, K061699, K141972, K171181, K142119, and K123392).

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.